USC and Bodyport Remote Heart Failure Management Study

NCT04975633 | Completed FDA Device

• 1 other identifier: HS-21-00032
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility study investigating the Bodyport virtual cardiac clinic vs usual care for outpatient heart failure management at Keck Medical Center of USC

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Change in quality of life

  Evaluating Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements at the time of hospital discharge and 90-days post-discharge

  Up to 14 days after enrollment and approximately 90-days post-enrollment

• Scale Adherence

  Measure of daily scale adherence

  Through study completion, approximately 90 days

Secondary Outcomes (1)

• Patient and provider satisfaction

  Through study completion, approximately 90 days for patients and an average of 9 months for providers.

Study Arms (2)

BodyPort Cardiac Scale

EXPERIMENTAL

Patient will receive the Bodyport scale with access to Bodyport care services, such as remote monitoring, educational materials, different biomarkers detected by the scale, and online access to their data

Device: Bodyport Cardiac Scale

Control

NO INTERVENTION

Patients will receive usual care and a Bodyport scale that only displays weight and weight change. No other access to care services, features, or materials will be provided during this 90 day period

Interventions

Bodyport Cardiac Scale DEVICE

Patients will be instructed to take daily measurements for 90 days. Data will be transmitted to Bodyport and concerning findings (weight gain, change of impedance, elevated heart rate) will be reported back to the medical team. The medical team will either choose to act on the information given or continue to observe trends. Interventions may include titration of therapy, change in therapy, fluid restriction, sodium restriction and lifestyle modification

BodyPort Cardiac Scale

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HFrEF or HFpEF and hospital discharge for a heart failure exacerbation within 14 days of enrollment.
• years of age or older
• English speaking
• Able to safely stand on the Bodyport scale
• Patients must have a reliable and working phone for communication with the care team
• All patients should have access to the internet via a computer or mobile device to access the Bodyport care platform
• Patients must have a safe and secure place to store the Bodyport device

You may not qualify if:

• Weight \>375 lbs.
• History of repeatedly missing follow-up appointments or being unreachable by phone
• Inability to stand on the Bodyport scale for the duration needed to capture data
• Patient in jail or currently homeless
• Known or documented noncompliance with medical therapy
• Unable to speak English
• Unable or unwilling to answer survey questions
• History of heart transplantation
• Chronic kidney disease stage IV or V and/or on hemodialysis
• Presence of a ventricular assist device
• Presence of a CardioMEMs pulmonary artery sensor

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael W Fong, MD

  Keck Medical Center of USC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: July 23, 2021
• Study Start: May 10, 2021
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)